Skip to content

Incidence and Severity of Silent and Apparent Cerebral Embolism After Conventional and Minimal-invasive Transfemoral Aortic Valve Replacement

Incidence and Severity of Silent and Apparent Cerebral Embolism After Conventional and Minimal-invasive Transfemoral Aortic Valve Replacement

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00883285
Enrollment
60
Registered
2009-04-17
Start date
2009-04-30
Completion date
2013-12-31
Last updated
2014-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Valve Disease, Cerebral Stroke

Brief summary

The purpose of this study is to compare the incidence of silent and apparent cerebral embolism between conventional and minimal-invasive transfemoral aortic valve repair.

Detailed description

Patients undergoing aortic valve repair (AVR) are included prospectively into the study. AVR techniques include the conventional technique, the transfemoral and the transapical approach. Before the intervention CT of the chest is performed preoperatively to assess the degree of aortic and aortic valve calcification. Patients undergo MRI of the brain, including diffusion weighted imaging (DWI) and neurological assessment (NIHSS score) within 48 h before and after the procedure to assess occurrence of cerebral embolism.

Interventions

None listed

Sponsors

University Hospital, Bonn
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* aortic valve replacement

Exclusion criteria

* contraindication to undergo MRI

Design outcomes

Primary

MeasureTime frame
Silent cerebral embolism48 hours

Secondary

MeasureTime frame
Apparent cerebral embolism48 hours

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 1, 2026